DE102019121841A1 - Medical fluid sampling system with a sample / collection container with culture medium or test field and culture medium preparation procedure - Google Patents

Abstract

The present disclosure relates to a medical sample / withdrawal container (1) which has a connector (2) for withdrawing a fluid to be examined from a fluid line and / or fluid collection system (F), which is integral with a withdrawal system (S), in particular a syringe, is formed or can be attached / attached directly to it, in such a way that a negative pressure can be built up in the sample / removal container (1) by actuating the extraction system (S) in order to supply it with the fluid through the connector (2) fill which has at least one nutrient medium (10) integrated therein for the cultivation of microorganisms or a test field for the display of analytes, and which has a spacer arrangement or a separating element, which / s the culture medium or the test field to components of the extraction system, in particular a syringe plunger ( 5) and / or a syringe cylinder (3), which when the extraction system (S) is actuated relative to the nutrient medium (10) or the test field are moved, spaced to prevent damage to the nutrient medium (10) or the test field. Furthermore, the present disclosure relates to a nutrient medium preparation method with the medical sample / extraction container (1).

Description

Technical background

The present invention relates to a medical fluid sample extraction system with a medical sample / extraction container with connector for extracting a fluid to be examined, in particular a body fluid or a fluid coming into contact with such, from a fluid line and / or fluid collection system, in particular a catheter or a collection container. The present disclosure also relates to a nutrient medium preparation method using the medical sample / draw container.

As part of point-of-care diagnostics, examinations of body fluids or fluids in contact with them take place. An example of this is examining urine (urinalysis). This contains bacteria or other microorganisms which can be cultivated and propagated for better examination. A urine culture can be created, for example, by dripping the urine onto a nutrient medium, usually a variant of agar-agar, or by dipping the nutrient medium into a urine sample. This medium is then incubated for approximately twenty-four hours in an incubator. The culture medium is examined in the laboratory. After twenty-four hours of incubation, the result is examined either visually or microscopically by smearing the colonies on the sample carriers for further microscopy. The status of the colonization with bacteria or other microorganisms can then be assessed in order to determine the type of bacteria based on this information, to draw conclusions about their antibiotic resistance and to determine the severity of the possible infection.

In addition to urine, many other liquids are incubated with the help of culture media as part of point-of-care diagnostics and then analyzed

State of the art

• • Nitrit (wird z.B. von manchen Keimen aus Nitrat gebildet und deutet deshalb auf eine Harnwegsinfektion hin),
• • Urobilinogen (entsteht aus Bilirubin und deutet als ein Abbauprodukt von Hämoglobin auf eine Lebererkrankung hin),
• • Erythrozyten (deutet auf eine Entzündung der Harnwege hin),
• • Leukozyten (können bei einer Entzündung der Niere oder Blase auftreten),
• • Proteine (insbesondere Albumin weit auf eine Nierenerkrankung hin),
• • pH-Wert (ein alkalischer pH-Wert tritt bei Infektionen der Harnwege auf, wohingegen ein saurer pH-Wert auf Diabetes hinweist),
• • Ketone (deuten auf einen verstärkten Fettabbau bei Stoffwechselerkrankungen hin),
• • Glucose (deutet auf Diabetes hin und kann auch bei manchen Krebsarten auftreten),
• • Dichte (kann u.a. auf eine Nierenerkrankung hinweisen, falls die Dichte trotz geringer Flüssigkeitsaufnahme gering bleibt),
• • Ascorbinsäure (gibt zwar keine Auskunft über den Gesundheitszustand des Patienten, kann aber die Messung von anderen Parametern zuverlässig gestalten).

According to the generally known prior art, a urinalysis can be carried out, for example, by dipping commercially available test strips into the urine, which is located in a test vessel for this purpose. These test strips usually have several test fields that change their color in the presence of the analyte to be examined and its concentration. Common parameters that can be determined using such test strips include

• • Nitrite (is formed from nitrate by some germs and therefore indicates a urinary tract infection),
• • urobilinogen (arises from bilirubin and, as a breakdown product of hemoglobin, indicates liver disease),
• • red blood cells (indicating inflammation of the urinary tract)
• • white blood cells (which may occur when the kidney or bladder is inflamed)
• • proteins (particularly albumin, indicating kidney disease),
• • pH value (an alkaline pH value occurs in urinary tract infections, whereas an acidic pH value indicates diabetes),
• • Ketones (indicate an increased breakdown of fat in metabolic diseases),
• • glucose (indicates diabetes and can also occur in some types of cancer),
• • Density (can indicate a kidney disease if the density remains low despite low fluid intake),
• • Ascorbic acid (does not provide any information about the patient's state of health, but can reliably measure other parameters).

To examine the urine of a catheterized patient, for example, a tube that leads from the patient to a urine collection bag is clamped off for a few minutes so that urine can collect up to the clamped point. If there is sufficient urine, the medical staff will use a syringe to remove urine from the extraction point provided for this purpose in the hose, which is preferably located on a stepped cone between the bag hose and the catheter. For this purpose, the syringe has either a cannula or a Luer slip / lock attachment. The urine drawn into the syringe is then transferred to another vessel and sent to an appropriately equipped laboratory, where the nutrient medium (or test strip / field) is immersed. In some cases, however, the urine is also allowed to drip directly from the tube onto the nutrient medium / test field inside the test vessel. After a few minutes, the result can be read from a reference color card. The test vessel containing the urine is then emptied and disposed of.

Another liquid that does not come directly from the patient, but is / was at least temporarily in contact with him or at least a component of him, is the so-called dialysis liquid during dialysis treatment ( extracorporeal blood treatment). A parameter that is usually to be examined here is the pH value of the dialysis fluid. Since the dialysis fluid is in contact with the patient's blood via the semipermeable membrane in the dialyzer, a pH value that is set too high or too low can have serious effects on the patient. Regular checks can therefore be useful. Similar to urinalysis, dialysis fluid must be regularly withdrawn for this purpose, for example by passing it into a separate test vessel in which a correspondingly designed test strip or pH indicator paper is then held.

For the use of conventional nutrient media or test fields, open (test) vessels in particular have so far been required, which represent potential sources of infection for the nursing staff. A sufficient volume of urine is also required to immerse a nutrient medium / test field. In addition, urine can drip onto the floor between the patient and the bag when it is removed from the urine collection bag or the supply tube, which then has to be wiped away and which can affect hospital hygiene. Today's urine collection, which is common in everyday clinical practice, always represents a certain amount of additional work for the nursing staff. For reasons of time, it is not uncommon for a urine analysis not to take place and a possible infection of a patient to be detected too late. In addition, the sample can be contaminated each time it is transferred to another vessel, be it from the ambient air or an incorrectly stored sample vessel.

A well-known system for taking urine samples is the Monovette available on the market. This system has a sample / withdrawal container which has a suction tip for withdrawing urine directly from a catheter, for example is filled like a syringe and is then suitable for further examination in the laboratory, for example for centrifugation. For a chemical urine analysis, however, it is intended to open the sample / collection container and immerse a test strip in it. One of the problems with this system is that an open sample / withdrawal container has to be used for such a urinalysis, which results in the hazards and inadequacies already described above. This also applies if you want to transfer urine, which was taken using this system, to a culture medium / test field.

Summary of the invention

It is an object of the present invention to provide a sample / removal container which reduces or eliminates the disadvantages of the prior art. In particular, a test vessel is to be provided which allows the samples to be handled safely and quickly. It should also be ensured that the samples taken provide the most accurate measurement results possible.

The essence of the present invention to solve the problem is in principle that the applicant of the present invention has recognized that for the previous, known from the prior art sequence of sampling and transferring into a test vessel, transport and final analysis in the laboratory an inaccuracy in the measurement result is to be expected. The content of the sample can change chemically every minute. Oxidation can produce by-products (e.g. conversion of bilinogen to urobilinogen) and waiting times also allow bacteria to penetrate the sample and change it. In addition, the sample container must always be opened for the commissioned measurement series. This is bad for the sample itself but also for the personnel who have to handle the opened sample containers.

To avoid this, the present invention offers the measure of using a sample / withdrawal container of a sampling system (e.g. syringe) at the same time as a device for the permanent storage of nutrient media (or test strips / fields) within the withdrawal container (e.g. syringe cylinder) for incubation from to further develop fluids originating from the body or fluids in contact with them, so that a quick, clean and safe process can be carried out in the extraction device itself (i.e. with the extraction process) without additional measures such as removing the extraction container, opening the extraction container and dipping a test strip, etc. Analysis of the removed liquid can be carried out in a quasi-closed system (without opening and decanting).

This means that the sample / collection container of the sample collection system is already provided with a nutrient medium / test strip / etc. basically equipped and (preferably not obviously - with the exception of the connector for withdrawing fluid from the patient / reservoir) closed. If the fluid / liquid sample is now sucked in by the patient or a reservoir to be examined using the sampling system (syringe) and thus the withdrawal container is filled, the nutrient medium (or test strip / field) already contained therein (which is integral with the withdrawal container) is simultaneously with the liquid wetted.

In other words, the object on which the invention is based is achieved by a medical sampling system (syringe) with a Sample / removal container, which has a connector (eg syringe needle, Luer slip / lock, etc.) for removing a fluid to be examined, in particular a body fluid or a fluid coming into contact with such, from a patient or a fluid line and / or a fluid collection system, in particular a catheter or a collection container. The sample / removal container is formed integrally with the removal system, in particular a syringe, or can be attached / attached directly to it in such a way that a (removal) negative pressure can be built up in the sample / removal container by actuating the removal system, in order to allow it to pass through the to fill the connector connected to the fluid line and / or fluid collection system with the fluid during the actuation of the extraction system. Furthermore, the sample / removal container already has a nutrient medium integrated in it for the cultivation of microorganisms or a test strip / field for displaying analytes, the sample / removal container or the removal system having a spacing arrangement or a separating element which / s the nutrient medium / the test field is spaced apart from (relative to each other movable) components of the extraction system, in particular a syringe plunger and / or a syringe cylinder, which are moved relative to the nutrient medium / the test field when the extraction system is actuated. In this way, damage to the nutrient medium / test field can be prevented, for example as a result of a component (which is movable relative thereto) being swept over the nutrient medium / test field.

It should be pointed out that the "spacing" is to be understood in such a way that a main area of the nutrient medium, which is necessary for the flat cultivation of microorganisms, or the test field is spaced from the corresponding components, e.g. to prevent them from being scraped off. It should not be ruled out that a (circumferential) edge of the nutrient medium / test field may touch the corresponding components, since damage to the same can be neglected in the context of the intended use.

In other words, a medical fluid extraction system is provided with a medical sample / extraction container, which makes it possible to extract a fluid to be examined, for example from an associated line / collection system, to soak a nutrient medium / test field for incubation with it or to wet and to incubate this nutrient medium / this test field, in particular together with the sample / collection container, or to bring it to the laboratory without the fluid ever having to be handled openly. This is achieved according to the invention in that only a single (extraction / suction) stroke of the extraction system is required in order to bring a fluid to be examined from the source / dispenser / reservoir directly into the container that receives / contains the nutrient medium / test field, which eliminates the need for a further (expressing) stroke. Furthermore, the nutrient medium / test field can be integrated or attached / attachable to the extraction device / extraction system, in particular the syringe, in such a way that damage to the nutrient medium / test field by a relative movement of components of the extraction device / extraction system via a spacer arrangement or a separating element is prevented becomes. Accordingly, the invention enables a fluid to be examined to be handled and analyzed quickly, cleanly and safely. Accordingly, the present invention reduces the risk of infection for medical personnel. In addition, in the case of sample / collection containers with integrated test fields, the test fields are analyzed on-site with the patient (point of care). The rapid measurement made possible in this way (i.e., (quasi-) continuously or as required) enables any bacterial infection of the patient to be detected quickly and thus treated promptly. It also saves time in sampling and analysis.

In principle, the sample / extraction container of the fluid extraction system / fluid extraction device can have different shapes, for example a cylinder, tube or cuboid shape, or it can be formed integrally with the extraction system. If necessary, a set of sample / removal containers with different or differently sized nutrient media / test fields can be provided. Various advantageous configurations of the spacer arrangement or the separating element and the attachment of the nutrient medium / test field are explained in more detail below.

Advantageous refinements are the subject matter of the dependent claims and are described in detail below.

According to one aspect of the invention, the medical fluid extraction system with the sample / extraction container is designed as a syringe, or in other words, is designed integrally therewith. In the syringe, the syringe cylinder and a pressure element of the syringe plunger define a fluid receiving space in which the nutrient medium / test field is (integrally) exposed. The pressure element has, for example, a rubber disc (plunger plate) and is accommodated in the syringe cylinder in a sealing and longitudinally displaceable manner.

A syringe is a particularly easy-to-use device that is known to every medical user and does not require any special handling or training. There is also a syringe easy and inexpensive to manufacture and a number of lost parts is reduced. The fluid extraction system or the syringe can preferably be dismantled, for example for cleaning purposes, so that the nutrient medium / test field can preferably also be handled individually before and in particular after the incubation.

Preferably, a length of the sample / collection container (syringe cylinder) is greater than a length of the syringe plunger (stroke length) and the spacer arrangement or the separating element is provided via a stop between the syringe cylinder and the syringe plunger, preferably at a proximal actuating end of the syringe / syringe plunger to define a minimum volume of fluid receiving space, which occurs when the piston is completely pushed into the cylinder. The stop can be formed, for example, by a change in diameter, in particular a step or an end surface, of the syringe cylinder and / or the syringe piston. In other words, the stop can be provided by proximal actuation and holding elements or grip elements, as are also provided in commercially available syringes, which corresponds to a standardized system and is particularly inexpensive and easy to manufacture. In contrast to commercially available syringes, however, the actuation shaft / syringe plunger is shortened compared to the syringe cylinder or the pressure element is arranged further proximally, so that a (predetermined) gap / distance remains between a distal end of the syringe cylinder and the plunger plate, in which the nutrient medium / test field is arranged . The size of the gap in which the nutrient medium / test field is accommodated is particularly easy to set in terms of design, for example by displacing an axial stop on the syringe piston in its longitudinal direction. It is also conceivable to make the stop adjustable for the user (sliding ring on the syringe plunger) in order, for example, to be able to insert differently sized nutrient media / test fields into the syringe cylinder in advance. Alternatively or in addition, a part of the syringe plunger can serve as the spacer or the separating element, which protrudes beyond the pressure element in order to be supported distally on a connector end of the syringe cylinder.

The nutrient medium / test field is preferably attached to an inner wall of the syringe cylinder directly or via a carrier plate. The carrier plate can preferably be removable from the syringe cylinder for further examinations, in particular after the incubation, for example via a plug-in system. If necessary, a set of carrier plates with different nutrient media / test fields can be provided. It is advantageous if the nutrient medium / test field is attached to a distal end or the connector end of the syringe cylinder so that the nutrient medium can safely be accommodated in the gap provided by the spacer arrangement between the syringe plunger and the connector end / distal end. Alternatively or additionally, the nutrient medium / test field can be attached to the pressure element of the syringe plunger. This is easy and inexpensive to manufacture due to the good accessibility of the syringe plunger during manufacture.

Furthermore, it is alternatively or additionally preferred if the syringe plunger has an actuating shaft (plunger plunger) connected to the pressure element / plunger plate, which extends through the pressure element into the fluid receiving space (pin-like) and at which (on the pin-like extension) the nutrient medium / the Test field is attached. In this case, it is further preferred if the actuating shaft, at least its part protruding / extending distally into the fluid receiving space, has a non-circular, preferably minus, cross, star, or rectangular cross-section in order to provide a number of shaft flanks (large-area ) To provide attachment of the nutrient medium / test field, which are spaced from the syringe barrel. In principle, it only needs to be ensured that sections, in particular longitudinal sections of the actuating shaft within the fluid receiving space are spaced apart from the inner wall of the syringe cylinder. Alternatively or in addition, the actuating shaft, at least its part protruding / extending distally into the fluid receiving space, can be tubular, with the culture medium / test field being attached to its inner wall and / or outer wall. This configuration of the syringe plunger makes it possible to provide a particularly large total area for attaching nutrient media / test fields. This is particularly advantageous if it is intended to carry out a large number of examinations with the sample taken.

In the case described above, the spacer arrangement or the separating element can be axially positioned via a stop formed on the syringe cylinder between a proximal connector end on the syringe cylinder (distal cylinder end wall) and a distal end of the actuating shaft (plunger plate) and / or by radial outer edges of the non-circular cross section of the actuating shaft or, in the case of the tubular operating shaft, be provided by a tube wall. If no radial outer edges or a radial outer side are provided on the actuating shaft, the pressure element / piston plate serves in the radial direction as the spacer arrangement or the separating element, which then comes into contact with axial stops on the cylinder and so the maximum ejection stroke (minimum fluid receiving space) limited. This represents a particularly rigid, stable variant of the spacer arrangement or the separating element.

It is of course also possible to provide axially extending support legs on the plunger plate, which are supported against the syringe cylinder end wall and thus define the minimum fluid receiving space in which the culture medium / test field is attached either to the syringe cylinder or to the plunger plate.

It should be noted that all of the above-described configurations of the spacer arrangements or the separating elements can be combined and / or can be provided in combination with different arrangements of the nutrient media / test fields. For example, both the stop on the proximal end of the syringe and the distal stop of the actuating shaft, which protrudes beyond the pressure element / plunger plate, can be installed in the syringe cylinder in combination with one on the actuation shaft and / or the pressure element and / or on the cylinder wall and / or on a Support plate provided nutrient medium / test field be provided. A stop between an edge of the carrier plate and the distal end of the syringe plunger can also serve as a spacer arrangement / separating element.

According to a further aspect of the invention, the medical sample / removal container can be designed as a test vessel defining a closed fluid receiving space, which has the removal connector and can be connected to it separately from the removal system, so that the sample / removal container is a flowable container through which the separate sampling system has to be filled in order to bring a sample / test field / nutrient medium to be investigated into contact with the fluid or to aspirate it in the sample / extraction container. In particular, the medical sample / collection container can be designed as a syringe attachment which, in addition to the connector, has a syringe connector through which a syringe nozzle (i.e., a connector of a syringe) can be connected to the syringe attachment. In other words, an adapter-shaped, medical sample / withdrawal container (receiving cylinder) is provided for a commercially available syringe, on one end wall of which a connector is formed which, as it were, simulates the syringe connector of the commercially available syringe and at the other end wall a connection for the syringe connector of the commercially available syringe is designed. In this case, the medical sample / removal container in the form of an adapter represents an axial extension of the syringe cylinder, which is integrated in the suction stroke of the syringe and is thus filled with a fluid sample when the syringe plunger is pulled out of the syringe cylinder (suction stroke).

A diameter of the essentially cylindrical sample / removal container (container adapter) can correspond to a diameter of the syringe used or be smaller than such. Furthermore, the adaptive sample / withdrawal container (adaptive syringe barrel attachment) can have a variety of other shapes, such as a cuboid shape, which possibly simplifies the attachment of nutrient media / test fields to the side walls of the adaptive sample / withdrawal container. The syringe connection for adaptively connecting the sample / removal container to the syringe connector of the syringe used is preferably provided at an end of the adaptive sample / removal container opposite the connector (removal connector of the adaptive sample / removal container). In particular, the (withdrawal) connector and the syringe connector can each be a Luer slip / lock connector. However, it is also possible to design the (withdrawal) connector as a syringe needle and the syringe connector as an elastic piercing membrane for the syringe needle on the commercially available syringe.

The design of the sample / removal container according to this aspect of the invention is particularly advantageous since in this way the sample / removal container can be used with any syringe. This means that the sample / withdrawal container itself is very simply constructed and therefore cheaper to manufacture, and there is no risk of confusion with conventional syringes with regard to the syringe to be used. In addition, the sample / removal container can be designed to be particularly small, space-saving and light and is easy to handle, in particular individually and without the syringe. Furthermore, it is advantageous that a fluid that is sucked into the sample / removal container is sucked out of the sample / removal container into the syringe and disposed of together with the syringe in the same work step as soon as the nutrient medium / test field is sufficiently wetted can. I.e. there is no need to operate the syringe a second time to expose the nutrient medium / test field from the fluid and a corresponding risk of contamination can be avoided.

According to the above aspect, the spacer arrangement or the separating element is preferably provided by an end of the sample / removal container which has the syringe connector / syringe connection and which separates an interior of the sample / removal container from an interior of the actual syringe (intake system). This is particularly advantageous because it also damages the nutrient medium / the Test field can be completely avoided by, for example, broken parts of a syringe plunger or a carrier plate, etc. This also ensures that the sample / removal container is a self-contained system that can be easily handled individually.

The syringe attachment / adaptive sample / removal container preferably has a removable closure and the nutrient medium / test field is attached to the closure or to an inner wall of the syringe attachment. In other words, the sample / removal container can be dismantled and a component having the nutrient medium / test field can be handled individually. This is particularly advantageous if the nutrient medium is to be examined further after the incubation, since it can be made more accessible in this way. The closure can be, for example, a plastic closure such as a rubber stopper, a screw-in / screwed-in cylinder or a screw-on / screw-on cap. The syringe connector on the sample / removal container can preferably be integrated into the closure. In this case it should be noted that the syringe connector or a through hole forming it must run through a nutrient medium or test field that may be attached to the inside of the closure.

Furthermore, it has proven to be advantageous if at least one element of the sample / removal container that has the nutrient medium / test field or preferably the entire sample / removal container is suitable for incubation. In this way, the necessary handling of the nutrient medium / test field can be minimized.

It is also advantageous to provide an outer carrier for reference color fields, which is connected or can be connected to the sample / removal container in order to be able to match (color) changes in the nutrient medium / test strip / test field (s). For example, this outer carrier can be designed in the form of a ring which can be pushed over the preferably cylindrical sample / removal container and rotated thereon. Alternatively or additionally, reference color fields can also be arranged inside the sample / removal container next to the at least one nutrient medium or test field, for example on the same carrier element (ie the component of the sample / removal container to which the culture medium / test field is attached) be.

According to a further advantageous embodiment, the extraction system for filling the sample / extraction container can build up a negative pressure by elastic deformation of the sample / extraction container. In this case, the sample / removal container is at least partially elastic / flexible. For example, a sleeve-shaped section of the sample / removal container is designed like a hose, which is closed at both ends, wherein it is closed at one end by a (rigid) end section having the removal connector. To fill the sample / extraction container, it is connected to the fluid line and / or fluid collection system via the extraction connector. A user then presses the elastic part of the sample / removal container together, with air possibly escaping into the fluid line / collection system or via a vent valve of the sample / removal container, and then releases it so that the restoring force of the elastic part creates a negative pressure the sample / extraction container and thus fluid is sucked into this from the fluid line / collection system through the extraction connector. This means that the user pumps fluid into the sample / removal container by repeatedly pressing and releasing the pressure.

• - Anschließen des Proben-/Entnahmebehälters über einen (Entnahme-) Konnektor an ein Fluidleitungs- und/oder Fluidsammelsystem,
• - Füllen/Einsaugen zumindest eines Teils des Proben-/Entnahmebehälters mit einem zu untersuchenden Fluid unter Verwendung eines Ansaugmechanismus (z.B. Einsaugkolben) des Entnahmesystems, derart, dass der Nährboden mit dem Fluid benetzt wird,
• - Vorzugsweise Auslassen zumindest eines Teils des in dem Proben-/Entnahmebehälter gefüllten/eingesaugten Fluids und/oder Ausrichten des Proben-/Entnahmebehälters, sodass der Nährboden das überschüssige, nicht an dem Nährboden haftende Fluid nicht kontaktiert, und Bereitstellen des Proben-/Entnahmebehälters zur Inkubation.

According to the embodiment explained above, the spacer arrangement can be provided in that the elastic part of the sample / removal container is arranged relative to the nutrient medium or the test field in such a way that they cannot come into contact with one another when the elastic part is compressed by the user. For example, the nutrient medium or the test field is arranged on a carrier element which protrudes into the fluid space and which has additional spacer arms which protrude beyond the nutrient medium or the test field. Alternatively or additionally, the elasticity of the elastic part is determined in such a way that the user can only compress the sample / removal container to a certain degree, so that a distance from the nutrient medium or test field is maintained. Alternatively or additionally, the nutrient medium is arranged in such a way that it is oriented away from the elastic part, for example within an annular carrier element or within / protected by an eg annular or plate-shaped, stiffened part of the sample / removal container. In addition, the object on which the invention is based is achieved by a nutrient medium preparation method for preparing a nutrient medium for incubation with or using a medical fluid extraction system described above with an (integrated) medical sample / extraction container. This procedure has the following steps:

• - Connecting the sample / extraction container to a fluid line and / or fluid collection system via a (extraction) connector,
• - Filling / sucking in at least a part of the sample / removal container with one to examining fluid using a suction mechanism (e.g. suction piston) of the extraction system in such a way that the culture medium is wetted with the fluid,
• - Preferably leaving out at least part of the fluid filled / sucked in the sample / removal container and / or aligning the sample / removal container so that the culture medium does not contact the excess fluid that does not adhere to the culture medium, and providing the sample / removal container for Incubation.

This method enables fluids to be examined from the medical environment, in particular body fluids such as urine, or liquids that come into contact with them, to be quickly, easily and safely removed and handled without the need to open the sample / removal container. A contamination of the sample, an infection of personnel or a spillage of the liquids to be examined can thus be effectively avoided. It is crucial that the suction process (carried out by the suction mechanism / syringe piston of the fluid sample extraction system / syringe) is used to fill the sample / withdrawal container (syringe cylinder / adaptive container) with the fluid sample, with the nutrient medium already in the sample / collection container has been inserted.

A commercially available syringe is basically made up of two parts with a syringe cylinder and a syringe plunger (plunger plate). Depending on where the field with the nutrient medium / test field is attached, several embodiments of the present invention are conceivable. On the one hand, the agar field can be provided on the rubber disc (pressure element) of the syringe plunger. On the other hand, the agar field or the test field can be provided on the plunger shaft (actuating shaft) of the syringe plunger. A further configuration of the shaft is possible in order to prevent leakage and to ensure that the field is wetted. The rubber disc, which closes the front of the shaft close to the syringe barrel, can be attached (approx. 1 to 2 cm) further back on the shaft. Part of the syringe plunger / shaft protrudes into the syringe barrel. Since the cross section of the shaft is preferably plus-shaped / cross-shaped, up to eight fields can be attached to it. However, it is also conceivable to design the shaft differently. Depending on the geometric shape of the shaft (minus, star-shaped, round, etc.), the number of possible separate agar fields or test fields on the shaft can vary.

Another possibility is to provide the agar field / test field on a plastic carrier (carrier plate) of any configuration within the syringe cylinder. In a further additional embodiment, a connection cone is provided, the agar field / test field being arranged within a cylinder / attachment which has two axially spaced connectors (Luer slip / lock connections). This cylinder can be connected to any syringe. In particular, the agar field / test field can be attached to a removable plastic closure. In this version, the agar field should be attached to the cylinder with a thread so that it can (optionally) be removed for incubation. The advantage of this variant is that you never come into contact with urine. This is sucked into a separate disposable syringe through the rear connection.

Regardless of the place of attachment, the device should be designed in such a way that the field / the culture medium / the test field can be removed from the vessel. The culture medium / test field including the carrying system is then incubated as a whole and / or examined in the laboratory. The transfer into the incubator is the only moment in which the field / the culture medium / the test field is exposed to the ambient air. It is also possible to incubate the entire vessel without any contact with the outside world.

Figure list

• 1 zeigt schematisch einen medizinischen Proben-/Entnahmebehälter nach einer ersten Ausführungsform der Erfindung.
• 2 zeigt schematisch einen medizinischen Proben-/Entnahmebehälter nach einer zweiten Ausführungsform der Erfindung.
• 3 zeigt schematisch einen medizinischen Proben-/Entnahmebehälter nach einer dritten Ausführungsform der Erfindung.
• 4 zeigt schematisch eine distale Draufsicht eines Spritzenkolbens des Proben-/Entnahmebehälters nach der dritten Ausführungsform.
• 5 zeigt schematisch eine Spritze mit einem medizinischen Proben-/Entnahmebehälter nach einer vierten Ausführungsform der Erfindung.
• 6 zeigt schematisch den Proben-/Entnahmebehälter nach der vierten Ausführungsform.
• 7 zeigt ein weiteres Beispiel eines Proben-/Entnahmebehälters nach der vierten Ausführungsform.
• 8 zeigt ein Beispiel einer Anordnung von Testfelder und Referenzfarbfeldern.
• 9 zeigt den Proben-/Entnahmebehälter nach der vierten Ausführungsform mit einem äußeren Ring mit Referenzfarbfeldern.
• 10 zeigt eine Anwendungssituation des Proben-/Entnahmebehälters nach der vierten Ausführungsform.
• Die ersten drei Ausführungsformen, welche nachstehend anhand von 1 bis 4 beschrieben werden, sind nach einem ersten Aspekt der Erfindung ausgebildet, gemäß welchem ein medizinischer Proben-/Entnahmebehälter 1 als eine Spritze S bzw. integral mit einer Spritze S ausgebildet ist.

The invention is described in more detail below with the aid of the attached figures with reference to preferred embodiments. These are merely illustrative in nature and are not intended to limit the scope of the invention. It is understood that individual features of the embodiments can be interchanged, modified or omitted. For better understanding, the same reference symbols are used in the following description for the same elements.

• 1 shows schematically a medical sample / removal container according to a first embodiment of the invention.
• 2 shows schematically a medical sample / withdrawal container according to a second embodiment of the invention.
• 3 shows schematically a medical sample / withdrawal container according to a third embodiment of the invention.
• 4th shows schematically a distal plan view of a syringe plunger of the sample / removal container according to the third embodiment.
• 5 shows schematically a syringe with a medical sample / removal container according to a fourth embodiment of the invention.
• 6th Fig. 13 schematically shows the sample / take-out container according to the fourth embodiment.
• 7th Fig. 13 shows another example of a sample / take-out container according to the fourth embodiment.
• 8th shows an example of an arrangement of test fields and reference color fields.
• 9 shows the sample / removal container according to the fourth embodiment with an outer ring with reference color fields.
• 10 Fig. 13 shows a situation of use of the sample / take-out container according to the fourth embodiment.
• The first three embodiments, which are explained below with reference to FIG 1 to 4th are designed according to a first aspect of the invention, according to which a medical sample / removal container 1 as a syringe S. or integral with a syringe S. is trained.

1 shows a schematic representation of a preferably as a syringe S. trained medical sample collection system with a sample / collection container 1 according to a first embodiment of the invention. As with a conventional syringe, the sample / collection container 1 of the sample extraction system has a syringe nozzle (extraction connector), which is designed, for example, as a Luer connector or a syringe needle, and as a connector 2 is used to remove a fluid to be examined from a patient or a fluid line and / or fluid collection system. The syringe nozzle / connector 2 is on a syringe barrel 3 of the sample extraction system connected (formed with this), which preferably has a larger diameter than the syringe nozzle / connector 2 having. The syringe barrel is at a proximal end (proximal end face) 3 open and has a plate-shaped, radially circumferentially outwardly extending projection / plate ring or retaining plate 4th on through which the syringe S. can be easily finger-gripped and operated.

Inside the syringe barrel 3 a syringe plunger is sealing and can be moved lengthways 5 the sampling system performed. The syringe plunger 5 has a pressure element / piston disc / piston head at its distal end 6th , for example an elastomer / plastic disc, which has a distal in the syringe barrel 3 formed fluid receiving space 7th seals. The syringe plunger also has 5 an operating shaft 8th , which on the printing element 6th is attached and extends in the proximal direction through the syringe barrel 3 extends. The operating shaft 8th has due to improved guidance within the syringe barrel 3 and, for reasons of stability, a cross-shaped cross-section, the resulting free longitudinal edges of the shaft possibly sliding against the syringe cylinder. At a proximal end of the actuator shaft 8th , which from the syringe barrel 3 protrudes, the syringe plunger points 5 an actuator plate 9 on which a user has to operate the syringe S. can pull or push to suit the pressure element 6th inside the syringe barrel 7th To move longitudinally and thereby a fluid in the syringe S. to suck or to squeeze out of it.

In contrast to a conventional syringe, the sample / removal container according to the invention 1 within the fluid receiving space 7th a breeding ground 10 pre-exposed, which for example on a distal surface of the pressure element 6th is appropriate. When filling the syringe S. by pulling on the flush plate 9 becomes the fluid receiving space 7th at least partially filled with a fluid such as urine, which is the nutrient medium 10 automatically / simultaneously wets or soaks. It should be noted that the preferably syringe plunger 5 shorter than the syringe barrel 3 is trained. That is, when the syringe plunger 5 completely into the syringe barrel 3 is inserted so that the actuator plate 9 of the piston on the retaining plate 4th of the cylinder rests, remains between a distal end (distal end wall) of the syringe cylinder 3 and that on the printing element 6th intended culture medium 10 a gap of a predetermined gap width, which is sufficient to absorb the nutrient medium. In other words, the retaining plate serve 4th and the actuator plate 9 as an axial stop and thus as a spacer arrangement or a separating element around the culture medium 10 prior to contact with the syringe barrel 3 and resulting damage to the culture medium 10 to protect. This is also advantageous, since it is due to the gap within the fluid receiving space 7th there is always enough air in it to provide a breeding ground 10 having area of the fluid receiving space 7th to fill when the sample / collection container 1 for incubation is aligned in the room in such a way that the urine contained therein moves in the direction of gravity at an area below the nutrient medium 10 collecting area. This applies to all of the variants of the spacer arrangement / separating element described in the context of this disclosure. As an alternative or in addition, it is possible to at least partially remove the urine taken up from the syringe before the incubation S. to push out.

2 Figure 11 shows schematically a medical fluid sampling / collection system with a medical sample / collection container 1 according to a second embodiment of the invention. This largely corresponds to the sample / extraction container 1 of the first embodiment, so below only the differences between the two embodiments are discussed.

The sample / collection container 1 the second embodiment essentially differs from that of the first embodiment in that the nutrient medium 10 is attached to an additional carrier plate, which is on the inner wall of the syringe barrel 3 is held to in the fluid receiving space 7th to be pre-exposed. More precisely, the carrier plate is with the culture medium 10 such on the inner wall at a distal end of the syringe barrel 3 attached that it is arranged within the gap, which due to the spacer arrangement or the separating element or the stop between the actuating plate 9 and the retaining plate 4th even with one as far as possible into the syringe barrel 3 inserted syringe plunger 5 between the distal end of the syringe barrel 3 and the printing element 6th of the syringe plunger 5 remains. Thus is the breeding ground 10 against damage caused by the pressure element sliding along it 6th protected. A difference in length of the syringe barrel 3 and the syringe plunger 5 or a size of the gap may be the same as or different from that of the first embodiment. In particular, this difference or size can be due to a size of the nutrient medium 10 be adjusted.

3 shows schematically a medical sample collection system with a sample / collection container 1 according to a third embodiment of the invention. This largely corresponds to the sample / removal container of the first and second embodiment, which is why only the differences between this embodiment will be discussed below.

According to a special feature of the sample / collection container 1 (or the suction mechanism) of the third embodiment of the invention is the syringe plunger 5 designed such that part of the operating shaft 8th in the distal direction over the pressure element 6th protrudes and thus into the fluid receiving space 7th protrudes. The cross-shaped cross section of the operating shaft 8th forms a number of surfaces or flanks which are parallel to a longitudinal direction of the syringe barrel 3 run and which act as carriers for a number of nutrient media 10 to serve. In this case, the operating shaft is used 8th even as a spacer arrangement or a separating element, since its radially outer ends of the cruciform cross-section create a plant for the nutrient media 10 on the syringe barrel 3 especially during actuation of the syringe S. is prevented. In addition, a stop or a spacer arrangement or a separating element is provided in the longitudinal direction of the syringe, which as described above through the holding plate 4th and the actuator plate 9 and / or by an abutment of a distal end 11 of the operating shaft 8th at a distal connector end 12 of the syringe barrel 3 is formed.

4th shows schematically a plan view of the syringe plunger 5 according to the third embodiment from the distal direction. This is good for the cruciform cross-section of the operating shaft 8th recognizable, the webs of which extend radially outward to an outer edge of the pressure element 6th and thus to the inner wall of the syringe barrel 3 extend. There is a nutrient medium on the flanks of the webs 10 (ie a total of eight culture media 10 ) appropriate. Accordingly, according to this embodiment, there is a particularly large amount of space for nutrient media 10 provided.

5 shows schematically a medical sample collection system with a sample / collection container 1 according to a fourth embodiment of the invention. With regard to this embodiment, too, only the distinguishing features compared to the expressions described above will be discussed below. In particular, it should be noted that the sample / removal container 1 this embodiment, which is based on the 5 and 6th is described, is formed according to a second aspect of the invention, and separately to a (commercially available) syringe S. is adaptively attached or attachable.

According to the fourth embodiment of the invention is the sample / removal container 1 not integral with the syringe S. but is designed as an attachment and distally with a syringe nozzle (removal connector) of a syringe S. connectable. A conventional syringe can advantageously be used whose syringe nozzle (extraction connector) is compatible with a syringe connector (syringe connector). 13 on the proximal end wall of the sample / collection container 1 is. The sample / collection container 1 is explained below using 6th described in more detail.

The sample / collection container 1 According to the fourth embodiment of the invention, one has the (proximal) syringe connector 13 (e.g. Luer slip / lock connector) opposite distal end 12 a (removal) connector 2 which is preferably designed according to a conventional syringe nozzle (e.g. Luer slip / lock connector or alternatively a cannula or a lowered cannula) and is used to remove a fluid from a fluid line and / or fluid collection system (or patient). On the syringe connector and / or the withdrawal connector 2 A non-return valve can optionally be attached so that liquid can only flow in one direction through the hollow body / sample / removal container. Starting from the distal connector end 12 extends the sample / collection container 1 sleeve-like / cylinder-like in the proximal direction to the fluid receiving space 7th to train. At the proximal end is the sample / collection container 1 by a lock 14th , for example a rubber stopper or screw cylinder, in which the syringe connector 13 is trained. The syringe connector 13 is in this example by a in the closure 14th provided through hole (possibly closed with a piercing membrane). At a distal one, the fluid receiving space 7th facing surface of the lock 14th is the breeding ground 10 attached and in the fluid receiving space 7th pre-exposed. Alternatively or in addition, the nutrient medium 10 also on an inner wall of the sleeve-shaped part 15th of the sample / collection container 1 or an additional carrier inserted.

Accordingly, the sample / draw container 1 like a syringe attachment over the syringe connector 13 with a syringe nozzle of the syringe S. get connected. Then the connector 2 , ie, those through the sample / draw container 1 formed syringe nozzle, are connected to a fluid line and / or fluid collection system, so that with a (single) actuation of the syringe S. (Suction stroke) a fluid contained in the collection system into the sample / extraction container 1 and possibly through the syringe connector 13 additionally in the syringe S. is sucked, the nutrient medium 10 is wetted. In this embodiment, a proximal end, in particular the closure, is used 14th , as the spacer arrangement or the separating element, which / s the nutrient medium within the sample / removal container 1 from an interior of the syringe S. separates or at a distance and thus damage to the nutrient medium due to contact with the actuating shaft 5 the syringe S. prevented.

The sample / collection container 1 to 5 and 6th can be modified as follows to illustrate a further aspect of the invention. The syringe connector 13 is not connected (ie it remains closed) or is designed as a closure cap or a closure plug. Furthermore, the sleeve-shaped part 15th of the sample / collection container 1 elastic, for example tubular, formed. In this way, the elastic sleeve-shaped part 15th are compressed by a user and, when the user releases the compression, generates a negative pressure in the sample / removal container due to its elasticity and the resulting restoring force 1 through which the fluid is sucked.

In each of the embodiments described above, the sample / draw container is 1 in the form of the syringe or in the form of the attachment as a whole, can be incubated unopened. Alternatively, a respective element, which acts as a carrier for the nutrient medium 10 serves, that is, the syringe barrel 3 , the plunger of the syringe 5 , the sleeve-shaped part 15th of the attachment and / or its closure 14th , dismantled and incubated individually or handled individually after incubation.

It should be noted that, as an alternative or in addition to the nutrient medium shown and described by way of example in the figures, one or more test fields for displaying analytes can be correspondingly provided in the fluid receiving space. In this regard shows 7th a version of the sample / collection container 1 as a syringe attachment, the basic structure of which is already based on 6th was described, in which, however, a test field 10 is integrated instead of a nutrient medium. The test field 10 is on the inside of the sample / collection container 1 attached or is attached to a (separately formed) carrier unit 16, which the test field in the fluid receiving space 7th free flow around / exposed. At least one test field 10 is on the carrier unit 16 attached directly or located on a test strip 17th , which is on the carrier unit 16 is located. For attaching the at least one test field 10 on the carrier unit 16 or the test strip 17th form-fitting, force-fitting or material-locking mechanisms are possible.

Several parameter-specific test fields can be used 10a , 10b , 10c preferably on a test strip 17th or be provided in matrix form (ie side by side and one above the other). It is also possible that one or more test fields 10 , 10a , 10b , 10c or the carrier unit 16 to design / arrange in the form of a ring. The test fields 10a , 10b , 10c can be provided for the detection of several parameters or analytes and change color when they are present. Such test fields are used for example 10 , 10a , 10b , 10c for determining a pH value, the presence of nitrite, urobilinogen, erythrocytes, leukocytes, proteins, ketones, glucose, ascorbic acid, blood and / or their density. The number of parameters, ie, the test fields 10 , 10a , 10b , 10c , is not limited to these substances or sizes. Likewise, only a subset of the test fields can 10 , 10a , 10b , 10c be attached to the carrier unit or one or more of the test fields provided 10 , 10a , 10b , 10c be provided redundantly.

The dimensions (length, width, height) and a cross-sectional shape (round / angular / ellipsoidal, etc.) of the fluid space 7th (ie, the sample / draw container 1 ) can be varied, particularly depending on the size of the test field 10 or the test fields 10a , 10b , 10c or the carrier unit 16 so that a very compact design is possible.

If necessary, instead of the test fields shown 10a and 10c or in addition to this for assessing the color change of the test field 10b Reference color fields / cards 18a, 18b may be provided, which are preferably in the vicinity of the test field 10b are attached and with which it can be compared whether and, if applicable, in what concentration an analyte is present in the liquid to be examined. The same applies to the pH value and the density. For example, the reference color field for the "Nitrite" parameter 18a stand for “no nitrite present”, whereas the field 18b can stand for “nitrite present”. The color of the test field 10b is then used after taking a sample with the reference color fields 18a and 18b compared. 8th shows a further example of an arrangement of a test field 10b and reference color fields arranged next to it 18a and 18b , which are annular, that is, arranged side by side in the radial direction.

In the event that there are several gradations with regard to a color change, for example in order to be able to read off concentrations, the invention preferably provides an outer ring 19th in front. This is how in 9 shown, rotatable on the outside of the sample / removal container 1 attached and has several reference color fields 18th on. By turning the outer ring 19th can match the colors of the test field 10 with the colors of the reference color fields 18th proceed more easily. Alternatively, the reference color fields are 18th firmly on the sample / collection container 1 appropriate.

10 shows the sample / collection container 1 according to the fourth embodiment in the intended application. A fluid line or fluid collection system F. has a hose F1 , which has a (not shown) collection container (eg a urine bag) with a catheter F2 connects. A clamp F3 for damming the fluid is attached to the hose. A fluid line / fluid collection system-side extraction connector F4, preferably a stepped cone, is a fluid extraction point between the hose F1 and the catheter F2 intended. The sample / extraction container is placed in this fluid extraction point 1 (Test vessel) inserted. That is, the extraction connector 2 of the sample / collection container 1 is connected to the extraction connector F4 on the fluid line / fluid collection system. To the other end of the sample / collection container 1 becomes the withdrawal system S. (e.g. a syringe via the syringe connector 13 ) plugged / connected, with which a sample of the fluid / body fluid passes through or into the sample / removal container 1 can be sucked for analysis.

List of reference symbols

1

Sample / collection container

2

Syringe nozzle / withdrawal connector

3

Syringe barrel

4th

Retaining plate / projection / proximal actuation end

5

Syringe plunger

6

Printing element

7th

Fluid receiving space

8th

Operating shaft

9

Actuator plate / proximal actuator end

10

Culture medium / test field

10a, 10b, 10c

parameter-specific test fields

11

Distal end of the operating shaft

12th

Distal end / connector end of the syringe barrel

13

Syringe connector

14th

Clasp

15th

Sleeve-shaped part of the sample / collection container

16

Carrier unit

17th

Test strips

18 18, 18a, 18b

Reference color fields

19th

outer ring

S.

Withdrawal system / syringe

F.

Fluid line and / or fluid collection system

F1

tube

F2

Catheter F3 Clamp F4 Fluid line / fluid collection system-side extraction connector

Claims (12)

Medical fluid sample collection system (S) with a sample / collection container (1) which - has a withdrawal connector (2) for withdrawing a fluid to be examined, in particular a body fluid or a fluid coming into contact with such, from a fluid line and / or fluid collection system (F), in particular a catheter or a collecting container, or a patient, is formed integrally with the extraction system (S) or directly adaptively attachable / attached to it, in such a way that a vacuum can be built up in the sample / extraction container (1) by a preferably one-time actuation of the extraction system (S) in order to circulate it through the container-side Withdrawal connector (2), which is designed to be connected to the fluid line and / or fluid collection system (F) or the patient during the actuation of the withdrawal system (S), to fill with the fluid, - at least one nutrient medium (10 ) for the cultivation of microorganisms or a test field for displaying analytes, and - a distance d holding arrangement or a separating element which / s the nutrient medium (10) or the test field to components of the extraction system, which are moved relative to the nutrient medium (10) or the test field when the extraction system (S) is actuated, in order to prevent damage to the The nutrient medium (10) or the test field. Medical sampling / collection system (S) according to Claim 1 , which is designed as a syringe (S) in which a fluid receiving space (7) is defined by a syringe cylinder (3) and a pressure element (6) of the syringe piston (5), in which the nutrient medium (10) or the test field is pre-exposed . Medical sampling / collection system (S) according to Claim 2 , wherein a length of the syringe cylinder (3) is greater than a length of the syringe plunger (5) and the spacer arrangement via a stop between the syringe cylinder (3) and the syringe plunger (5), preferably at a proximal actuating end (4, 9) of the syringe , is provided to define a minimum volume of fluid receiving space. Medical sampling / collection system (S) according to Claim 2 or 3 , wherein the nutrient medium (10) or the test field is attached to an inner wall of the syringe cylinder (3) directly or via an additional carrier element. Medical sampling / extraction system (S) according to one of the Claims 2 to 4th , wherein the nutrient medium (10) or the test field is attached to the pressure element (6) of the syringe plunger (5). Medical sampling / extraction system (1) according to one of the Claims 2 to 5 wherein the syringe plunger (5) also has an actuating shaft (8) connected to the pressure element (6), which extends through the pressure element (6) into the fluid receiving space (7) and to which the nutrient medium (10) or the test field is attached . Medical sampling / collection system (S) according to Claim 6 , wherein the actuating shaft (8), at least its part protruding distally into the fluid receiving space (7), has a non-circular, preferably cruciform, star-shaped or rectangular cross-section in order to provide a number of shaft flanks for attaching the nutrient medium (10) or the test field, which are spaced from the syringe barrel (3). Medical sampling / collection system (1) according to Claim 7 , wherein the spacer arrangement is provided via a stop between a distal connector end (12) of the syringe cylinder (3) and a distal end of the actuating shaft (8) and / or by radial outer edges of the non-circular cross section of the actuating shaft (8). Medical sampling / collection system (1) according to Claim 1 , in which the medical sample / removal container (1) is designed as an adaptive syringe attachment defining a closed fluid receiving space (7), which in addition to the removal connector (2) arranged distally thereon has a proximally arranged syringe connector (13) on which a syringe (S) is connected or connectable to the adaptive syringe attachment. Medical sampling / collection system (1) according to Claim 9 , wherein the spacing arrangement is provided by an end of the sample / removal container (1) having the syringe connector (13) and which separates the fluid receiving space (7) of the sample / removal container (1) from an interior of the syringe (S). Medical sampling / collection system (1) according to Claim 9 or 10 , wherein the sample / removal container (1) has a preferably removable closure (14) for closing the front side of the fluid receiving space formed therein and the nutrient medium (10) or the test field on the closure (14) or on an inner wall of the syringe attachment (1 ) is appropriate. A nutrient medium preparation method for preparing a nutrient medium (10) for incubation with a medical sample / removal system (S) according to one of the preceding claims, comprising the steps of: connecting the sample / removal container (1) via the one formed or arranged thereon Extraction connector (2) to a fluid line and / or fluid collection system (F), - filling at least part of the sample / extraction container (1) with a fluid to be examined as part of a preferably single suction stroke of a suction mechanism of the sample / extraction system (S) , in such a way that the nutrient medium (10) preinstalled in the sample / removal container (1) is wetted with the fluid, - Preferably, at least part of the fluid filled in the sample / removal container (1) is let out and / or the sample / removal container is Withdrawal container (1), so that the nutrient medium (10) does not come into contact with the excess fluid that does not adhere to the nutrient medium (10), and at least the sample / withdrawal container (1) is made available for incubation.

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